Devices, systems and methods for re-alignment of bone

ABSTRACT

A bone re-angling device may be used in performing an osteotomy. The re-angling device may be a generally wedge-shaped body. The re-angling device maybe coupled to the bone using a fixation member.

FIELD OF THE INVENTION

The invention generally relates to devices, systems, and methods forrealignment of bone, e.g. during bony osteotomy.

BACKGROUND OF THE INVENTION

There are many occasions in orthopedic surgery when a bone is angledimproperly due to congenital deformity, trauma, failed surgeries, anduneven arthritic wear in joints. A surgical operation called anosteotomy is done to correct this misalignment. In an osteotomy the boneis cut and then realigned to correct the improper angle.

In an osteotomy procedure, the surgeon removes a wedge of bone near adamaged joint. The procedure shifts weight from an area where there isdamaged cartilage to an area where there either more cartilage orhealthier cartilage. In this manner, weight is spread more evenly acrossthe joint cartilage.

Osteotomy is commonly performed on the knee or hip joint. Osteotomy mayhelp correct knee deformities such as bowleg or knock-knee deformities.Osteotomy may also be used to correct damage due to arthritis. Forexample, osteotomy may be performed in patients too young for a totaljoint replacement.

It is desirable to provide a new device which both simplifies there-angling operations and enables correction to be more precise.

SUMMARY OF THE INVENTION

The invention provides devices, systems, and methods for re-aligning orre-angling a bone.

One aspect of the invention provides a system comprising a body sizedand shaped to re-align a bone region toward a desired anatomic positionand at least one fixation member for securing the body to the boneregion.

In one embodiment, the fixation member includes at least one fixationplate sized and configured for association with the body to secure thebody to the bone region.

In one embodiment, the fixation member comprises at least one screwand/or at least one staple and/or at least one stem.

In one embodiment, the body includes at least one aperture formedthrough it sized and configured for engagement with a fixation member.In this arrangement, the aperture can include internal threads forreceiving a screw.

In one embodiment, the body is generally wedge-shaped.

In one embodiment, the fixation member includes a fixation plate formedwith a first surface geometry. In this arrangement, the body includes asecond surface geometry that mates with the first surface geometry.

In one embodiment, the system further comprises a total jointreplacement including a stem. In this arrangement, the body includes anaperture formed through it sized and configured for engaging the stem.

Another aspect of the invention provides an osteotomy device comprisinga generally wedge-shaped body and at least one intramedullary postextending from the wedge-shaped body.

Another aspect of the invention provides a method comprising providing abody sized and shaped to re-align a bone region toward a desiredanatomic position and at least one fixation member for securing the bodyto the bone region. The method includes selecting an bone region,forming a cavity in the bone region sized and configured to receive thebody, and inserting the body in the bone region to re-aligned the boneregion toward a desired anatomic position. The method includes fixingthe body to the bone region with the fixation member.

Another aspect of the invention provides a method comprising providing abody sized and shaped to re-align a bone region toward a desiredanatomic position and at least one fixation plate sized and configuredfor association with the body to secure the body to the bone region. Themethod includes selecting an bone region, forming a cavity in the boneregion sized and configured to receive the body, and inserting the bodyin the bone region to re-aligned the bone region toward a desiredanatomic position. The method includes fixing the body to the boneregion with the fixation plate.

Another aspect of the invention provides a method comprising providing abody sized and shaped to re-align a bone region toward a desiredanatomic position, the body including at least one aperture formedthrough it sized, and a fixation member sized and configured forengagement with aperture. The method includes selecting a bone region,forming a cavity in the bone region sized and configured to receive thebody, and inserting the body in the bone region to re-align the boneregion toward a desired anatomic position. The method includes fixingthe body to the bone region by engaging the fixation member through theaperture.

Other objects, advantages, and embodiments of the invention are setforth in part in the description which follows, and in part, will beobvious from this description, or may be learned from the practice ofthe invention.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a top view of a foot.

FIG. 2 is a front view of a leg.

FIG. 3 is a perspective view of a re-angling device according to thepresent invention.

FIG. 4A is a plan view of a bone with a wedge shaped gap cut therein.

FIG. 4B shows a re-angling device of the type shown in FIG. 3 beinginserted into the bone of the type shown in FIG. 4A.

FIGS. 4C to 4F show a re-angling device of the type shown in FIG. 3being secured to a bone of the type shown in FIG. 4A using alternativefixation plate and fixation member.

FIGS. 5A and 5B show an alternative embodiment of a re-angling devicebeing inserted into a bone.

FIG. 6A is an exploded perspective view of an alternative re-anglingdevice and fixation plate wherein the re-angling device is formed with aprotrusion and the fixation plate is formed with a mating aperture.

FIG. 6B shows the alternative re-angling device and fixation plate ofFIG. 6A secured in a bone of the type shown in FIG. 4A.

FIGS. 6C to 6F show additional alternative embodiments of the re-anglingdevice and fixation plate of FIG. 6A.

FIG. 6G is an exploded perspective view of an alternative re-anglingdevice and fixation plate wherein the re-angling device is formed with aaperture and the fixation plate is formed with a mating protrusion.

FIG. 7A is an exploded perspective view of a alternative re-anglingdevice and fixation plate being inserted into a bone of the same typeshown in FIG. 4A.

FIG. 7B shows the alternative re-angling device and fixation plate ofFIG. 7A secured in a bone of the same type as shown in FIG. 4A.

FIG. 8 shows an alternative re-angling device with a integrally formedfixation plate secured in a bone of the same type as shown in FIG. 4A.

FIG. 9A is a perspective view of an alternative embodiment of are-angling device.

FIG. 9B shows the alternative re-angling device of FIG. 9A secured to abone of the same type as shown in FIG. 4A by a fixation plate andfixation members.

FIGS. 10A and 10B show an alternative re-angling device inserted into abone of the type shown in FIG. 4A.

FIGS. 10C to 10G show various alternative embodiments of the re-anglingdevice of FIG. 10A.

FIG. 10H shows the re-angling device of FIG. 10B secured in the bonewith a fixation plate and fixation members.

FIG. 11A is a perspective view of an alternative embodiment of there-angling device of FIG. 3 with a hole therethrough for a total jointreplacement stem.

FIG. 11B shows the re-angling device of FIG. 11A inserted into a bone.

FIG. 11C is a perspective view of an alternative embodiment of there-angling device like that shown in FIG. 11A, inserted into a bone withthe hole receiving a fixation pin.

FIG. 11D is a perspective view of an alternative embodiment of there-angling device like that shown in FIG. 11A, the hole being internallythreaded for receiving a screw.

FIG. 11E shows the re-angling device of FIG. 11E inserted into a boneand fixated with a screw through the hole.

DESCRIPTION OF THE PREFERRED EMBODIMENT

Although the disclosure hereof is detailed and exact to enable thoseskilled in the art to practice the invention, the physical embodimentsherein disclosed merely exemplify the invention which may be embodied inother specific structures. While the preferred embodiment has beendescribed, the details may be changed without departing from theinvention, which is defined by the claims.

FIGS. 1 and 2 show the anatomy of the human foot and leg, respectively.While it is contemplated that osteotomy may be in any part of the humananatomy, osteotomy is commonly performed on the metatarsal and thefemur.

I. Re-Angling Device with Separate Fixation Plate

FIG. 3 shows a device 10 for re-angling or realigning a bone regionaccording to the present invention. This device 10 is sized andconfigured to be inserted into a gap formed in the bone region toaccommodate placement of the device 10. The device 10 is sized andconfigured to re-angle or realign the bone region toward a desiredanatomic position, e.g., during an osteotomy procedure.

In a first illustrated embodiment, the re-angling device 12 is generallywedge shaped, and is sized and configured to fit into a wedge-shaped gapcut into the bone region. The size and configuration of the re-anglingdevice 12 can vary, as long as it functionally serves to re-angle orrealign the bone region in a desired manner.

In the embodiment shown in FIG. 3, the re-angling device 12 includes agenerally rectangular base 16, a pair of wedge surfaces 14 which extendfrom laterally opposed edges of the base 16 and meet at a point oppositethe base 16, and a pair of end surfaces 18 which extend from laterallyopposed edges of the base 16 and engage one edge of each wedge surface14.

In order to insert the device 12 into the bone 6, an appropriately sizedwedge of bone is removed from the application site, creating awedge-shaped gap 8, as shown in FIG. 4A. The application site is chosenby the physician based on the anatomy of the patient. The gap 8 iscreated using any appropriate surgical device, such as an appropriatelysized and configured surgical saw. The device 12 is then inserted intothe gap 8 in the bone 6 as shown in FIG. 4B. The device 12 may then besecured to the bone 6. The device 12 may be secured to the bone by anyknown method used in the art, for example, and not limited to bonecement, a temporary plate, and a permanent plate.

In one method of fixation, as shown in FIG. 4C, the device 12 is securedin the gap by placing a fixation plate 20 over the re-angling device 12.The fixation plate 20 is then attached to the bone 6 using a fixationmember 24. In some circumstances, it may be desirable to drill pilotholes in either the fixation plate 20 or the bone 6 prior to insertingthe fixation member 24. The fixation member 24 preferably extendsthrough the fixation plate 20 and into the bone 6 to secure there-angling device 12 to the bone 6.

In the embodiment shown in FIG. 4C, the fixation plate 20 takes the formof a single fixation plate 22 that extends across the entire length ofthe re-angling device 12.

It is also contemplated that the fixation plate 20 could take the formof multiple fixation plates 122, each of which extends across only aportion of the re-angling device, as shown in FIG. 4D.

In the representative embodiments shown in FIGS. 4C and 4D the fixationmembers 24 comprises screws 26, such as surgical screws. However, itshould be understood that the fixation members may be chosen from avariety of fixation members known in the art. For example, the fixationmember 24 could also be a bone staple 126, as shown in FIG. 4E or abarbed bone staple 226 as shown in FIG. 4F.

As shown in FIG. 4E, it may be desirable to provide the fixation plate20 with at least one preformed aperture 34 through which a fixationmember 24 may extend to secure the fixation plate 20 to the bone 6. Theaperture 34 may be threaded or not threaded depending on the type offixation member 24 to be used.

The size and shape of the device 10, fixation plate 20, and fixationmembers 24 are chosen by the physician based on each individualpatient's anatomy and the type of bone in which the device is to beused.

The device 10, the fixation plate 20, and the fixation members 24 may bemade of various materials commonly used in the prosthetic artsincluding, but not limited to, metals, ceramics, tantalum, polyethylene,biologic type polymers, hydroxyapetite, rubber, titanium, titaniumalloys, tantalum, chrome cobalt, surgical steel, or any other totaljoint replacement metal and/or ceramic, bony in-growth surface, sinteredglass, artificial bone, any porous metal coat, metal meshes andtrabeculations, metal screens, uncemented metal or ceramic surface,other bio-compatible materials, or any combination thereof.

It may be desirable to provide the device 10, the fixation plate 20, andthe fixation members 24 with surfaces, or a portion of a surface, thatallow for bony ingrowth. The surfaces of the device 10, fixation plate20, and fixation members 24 could be covered with biological bonesubstitute or biological stimulators for example, but not limited tohydroxygretite, calcium phosphate, calcium sulfate, or one of the bonemorphogenic stimulators. Alternatively, the surfaces of device 10, thefixation plate 20, and the fixation members 24 could be covered withsurface texturing to induce bony in-growth. The surface texturing cancomprise, e.g., through holes, and/or various surface patterns, and/orvarious surface textures, and/or pores, or combinations thereof. Thedevice 10 can be coated or wrapped or surfaced treated to provide thesurface texturing, or it can be formed from a material that itselfinherently possesses a surface conducing to bony in-growth, such as aporous mesh, hydroxyapetite, or other porous surface.

It may further be desirably for the device 10 to be covered with variouscoatings such as antimicrobial, antithrombogenic, and osteoinductiveagents, or a combination thereof.

II. Re-Angling Device Fixed with One or More Crossing Screws

It is further contemplated that the re-angling device 10 described abovemay be fixed by one or more fixation members inserted through thealternative re-angling device 112 as shown in FIGS. 5A and 5B. There-angling device 112 may take generally the same form as describedabove. However, in such an embodiment the need for a fixation plate 20is eliminated.

In order to insert the alternative re-angling device 112 into the bone6, an appropriately sized wedge of bone is removed from the applicationsite, creating a wedge-shaped gap 8, as shown in FIG. 4A. Thewedge-shaped gap 8 is formed using any appropriate surgical device, suchas an appropriately sized and configured surgical saw. As discussed inreference to the embodiments above, the application site is chosen bythe physician based on the anatomy of the patient. The size andparticular configuration of the alternative re-angling device 112 isalso selected by the physician based on the anatomy of the patient. Thealternative re-angling device 112 may then be inserted into the gap 8 inthe bone 6 and secured to the bone 8 by a fixation member 24 as shown inFIG. 5A. In the illustrated embodiment the fixation member 24 comprisesa threaded screw 26. The fixation member 24 is secured using anyappropriate surgical devices, such as an appropriately sized andconfigured surgical screwdriver. As shown in FIG. 5A, the screw 26 isscrewed though the re-angling device 112 and into the bone 6. It isfurther contemplated that multiple fixation members 24 could be utilizedto fasten a single re-angling device 112, as shown in FIG. 5B. It may bedesirable, but not necessary, to have a pilot hole in the re-anglingdevice 112 to aid in insertion of the at least one fixation member 24.The re-angling device could be preformed with an aperture, such as apilot hole 28, as shown in FIG. 5A. Alternatively, the pilot hole 28could be drilled in the device 112 by the surgeon either before or afterinserting the re-angling device 112 in the bone 6. The re-angling device112 and fixation members 24 may be formed of any appropriate prostheticmaterial as describe above, and if desirable may include surfacesadapted to promote bony-in-growth as also described above.

III. Re-Angling Device with Slot for Attachment to a Fixation Plate

In an additional representative embodiment, a re-angling device 10 maybe removably coupled to a fixation plate 20. As shown in FIG. 6A, there-angling device 112 and fixation plate 322 may take generally the sameform as described above. However, the re-angling device 112 includes afirst surface geometry 30 and the fixation plate 20 includes a secondsurface geometry 32 that nests or mates with the first surface geometry30. In the illustrated embodiment, the first surface geometry comprisesa female aperture 30 and the second surface geometry comprises a matingmale protrusion 32. The protrusion 32 is sized and configured to bereceived in the aperture 30 formed in the re-angling device 112. Themating male and female configurations may be reversed. That is, thefirst surface geometry on the device can comprise a male projection andthe second surface geometry on the device comprises a mating femaleaperture.

In the first representative embodiment, the protrusion 32 and theaperture 30 each take a tapered rectangular shape. The protrusion 32 andaperture 30 may take any shape including, but not limited to square (seeFIG. 6C), morse taper, triangular (see FIG. 6D), star-shaped (see FIG.6E), or round (see FIG. 6F).

The re-angling device 112 and the fixation plate 322 may be coupledprior to inserting the re-angling device 112 into the bone 6.Alternatively, the re-angling device 112 may first be inserted into thebone 6, then the fixation plate 322 may be coupled to the re-anglingdevice 112.

The fixation plate 322 is then fixed to the bone 6 by at least onefixation member 24, as shown in FIG. 6B and described in further detailabove. In the illustrated embodiment, the fixation member 24 takes theform of a screw 26, however it should be understood that the fixationmember 24 may take any form.

Alternatively the re-angling device 212 may be formed with a protrusion38 and the fixation plate 422 may be formed with a mating aperture 36,as shown in FIG. 6H. The illustrated embodiment includes a rectangulartapered protrusion 38 and a generally rectangular aperture 36, howeveras described above, the aperture 36 and protrusion 38 may take anymating shape.

In order to insert the device 112 into the bone, an appropriately sizedwedge of bone is removed from the application site, creating awedge-shaped gap 8, as shown in FIG. 4A. The application site is chosenby the physician based on the anatomy of the patient.

The re-angling device 112,212, fixation plate 322,422 and fixationmembers 24 may be formed of any appropriate prosthetic material asdescribe above, and if desirable may include surfaces adapted to promotebony-in-growth as also described above.

IV. Re-Angling Device with Hole for Screw Attachment to a Fixation Plate

In an additional representative embodiment both the re-angling device 10and the fixation plate 20 may be preformed with an aperture. As shown inFIG. 7A, an aperture 530 is formed in the re-angling device 112 and anaperture 136 is formed in the fixation plate 422. In this manner, thefixation plate 422 may be fixed to the re-angling device 112 via afixation member 24 such as a screw 26, as shown in FIG. 7B.

It is contemplated that the aperture 136 in the fixation plate 422 andthe aperture 530 in the re-angling device 112 could be threaded as shownin FIG. 7A, or unthreaded. It is also contemplated that the aperture 136in the fixation plate 422 could be threaded while the aperture 530 inthe re-angling device 112 is not threaded, or vice versa.

It may be desirable, although not necessary, to provide the fixationplate 422 with at least one aperture 34 through which the fixationmembers 24 may extend as shown in FIG. 7A. It may be desirable, but notnecessary, to provide the at least one aperture 34 with internal threadsas shown in FIG. 7A.

The re-angling device 112 is generally wedge-shaped, as described above.The size and specific configuration of the re-angling device 112,fixation plate 422, and fixation members 24 are chosen by the physicianbased on each individual patient's anatomy and the type of bone in whichthe device 112 is to be used. The re-angling device 112 and the fixationplate 422 may be attached prior to inserting the re-angling device 112into the bone 6, or after the re-angling device 112 has been insertedinto the bone 6.

As described above with respect to the previous embodiments, in order toinsert the re-angling device 112 into the bone 6, an appropriately sizedwedge of bone is removed from the application site, creating awedge-shaped gap 8, as shown in FIG. 4A. The wedge-shaped gap 8 isformed using any appropriate surgical device, such as an appropriatelysized and configured surgical saw. As discussed in reference to theembodiments above, the application site is chosen by the physician basedon the anatomy of the patient. The size and particular configuration ofthe re-angling device is also selected by the physician based on theanatomy of the patient. The re-angling device 112 is then inserted intothe gap 8 in the bone 6 and secured to the bone 6 by a fixation member24 as shown in FIG. 7B. In the illustrated embodiment the fixationmember 24 comprises a threaded screw 26, however it should be understoodthat any appropriate fastener may be utilized. The fixation member 24 issecured using any appropriate surgical devices, such as an appropriatelysized and configured surgical screwdriver. As shown in FIG. 7B, thescrew 26 is screwed though the fixation member 422 and into the bone 6.

The re-angling device 112, fixation plate 422 and fixation members 24may be formed of any appropriate prosthetic material as describe above,and if desirable may include surfaces adapted to promote bony-in-growthas also described above.

V. Re-Angling Device with Integral Fixation Plate

In an additional representative embodiment, the re-angling device 10 andthe fixation plate 20 are integrally formed as a single device 312, asshown in FIG. 8. The alternative re-angling device 312 may takegenerally the same wedge-shaped configuration as described above.

To insert the device 312 into the bone 6, an appropriately sized wedgeof bone 6 is removed from the application site, creating a wedge-shapedgap 8, as shown above in FIG. 4A. The application site is chosen by thephysician based on the anatomy of the patient. The device 312 is theninserted into the gap 8 in the bone as shown in FIG. 8 and secured tothe bone 6. In one embodiment, the re-angling device 312 may be fixed tothe bone through at least one fixation member 20. In the illustratedembodiment, the fixation member 20 takes the form of a screw 26.However, the fixation member 20 may comprise any suitable fixationmember, including, by means of example a surgical screw or a surgicalstaple. As described above, and shown in FIG. 7A, it may be desirable,although not necessary to include apertures 34 in the fixation plateportion 22 of the device 312 through which the fixation members 24 mayextend. It is further contemplated that in some situations it may bedesirable, although not necessary, to provide the apertures 34 in thefixation plate portion 22 with pre-formed threads, as described indetail above.

The size and the particular configuration of the re-angling device 312are preferably chosen by the physical based on the anatomy of thepatient being treated.

The re-angling device 312 and fixation members 24 may be formed of anyappropriate prosthetic material as describe above, and if desirable mayinclude surfaces adapted to promote bony-in-growth as also describedabove.

VI. Wedge with Angle in Two Planes

In an additional representative embodiment shown in FIGS. 9A and 9B, there-angling device 412 may be formed such that the bone 6 may be angledin two planes. The configuration of the re-angling device is similar tothat shown in FIG. 3 and described above, however the base 416 isgenerally trapezoidal, rather than rectangular.

To insert the device 412 into the bone 6, an appropriately sized wedgeof bone 6 is removed from the application site, creating a wedge-shapedgap 8, as shown above in FIG. 4A. The application site is chosen by thephysician based on the anatomy of the patient. The device 412 is theninserted into the gap 8 in the bone as shown in FIG. 9B and secured tothe bone 6. In one embodiment, the re-angling device 412 may be fixed tothe bone through at least one fixation member 20. In the illustratedembodiment, the fixation member 20 takes the form of a screw 26.However, the fixation member 20 may comprise any suitable fixationmember, including, by means of example a surgical screw or a surgicalstaple. As described above, and shown in FIG. 7A, it may be desirable,although not necessary to include apertures 34 in the fixation plateportion 22 of the device 312 through which the fixation members 24 mayextend. It is further contemplated that in some situations it may bedesirable, although not necessary, to provide the apertures 34 in thefixation plate portion 22 with pre-formed threads, as described indetail above.

The size and the particular configuration of the re-angling device 412are preferably chosen by the physical based on the anatomy of thepatient being treated.

The re-angling device and fixation members may be formed of anyappropriate prosthetic material as describe above, and if desirable mayinclude surfaces adapted to promote bony-in-growth as also describedabove.

VII. Re-Angling Device with Intramedullary Post

In an additional representative embodiment, the re-angling device 512may include at least one intramedullary post 40, as shown in FIG. 10A.The intramedullary post 40 may extend into the bone 6 to further securethe re-angling device 512 within the bone 6.

To insert the device 512 into the bone 6, an appropriately sized wedgeof bone 6 is removed from the application site, creating a wedge-shapedgap 8, as shown above in FIG. 4A. At least one aperture may be formed inthe bone 6, the aperture being adapted to accept the at least oneintramedullary post 40. The application site is chosen by the physicianbased on the anatomy of the patient. The device 512 is then insertedinto the gap 8 in the bone as shown in FIG. 8 and secured to the bone 6.The size and the particular configuration of the re-angling device 512are preferably chosen by the physical based on the anatomy of thepatient being treated.

It is further contemplated that the re-angling device 512 could beformed with a pair of posts 40, as shown in FIG. 10B.

It is further contemplated that the post 40 on the re-angling device 512could take any shape. For example, the post could be square (see FIG.10C), star-shaped (see FIG. 10D), triangular (see FIG. 10E), rounded(see FIG. 10F) or pointed (see FIG. 10G).

The re-angling device 512 may be formed of any appropriate prostheticmaterial as describe above, and if desirable may include surfacesadapted to promote bony-in-growth as also described above.

VIII. Re-Angling Device for Use with Stem of Total Joint Replacement orInternal Fixation

It is also contemplated that any of the re-angling devices describedabove may be formed with a hole 44 therethrough as shown in FIG. 11A.

The hole 44 may be sized and configured for the particular application.For example, the hole 44 may be sized and configured such that when there-angling device 612 is inserted into the bone 6, the stem 46 of atotal joint replacement may be inserted through the hole 44, as shown inFIG. 11B. Alternatively, the hole 44 may be sized and configured forreceiving a pin 48, as shown in FIG. 11C. Alternatively, the hole 44 maybe internally threaded, as shown in FIG. 11D, and be sized andconfigured for receiving a screw 50, as shown in FIGS. 11D and 11E. Inany embodiment, the basic configuration of the re-angling device 612 isthe same as described above. The particular size and configuration ofthe device 612 is determined by the physician based on the bone beingtreated and the anatomy of the patent.

In order to insert the device 612 into the bone, an application site ischosen by the physician based on the anatomy of the patient. Anappropriately sized wedge of bone is removed from the application site,creating a wedge-shaped gap 8, as shown in FIG. 4A. The device 612 maythen be inserted into the gap in the bone as shown in FIG. 11B. Thedevice 612 may then be secured to the bone 6 by any known method used inthe art. For example, the device 612 may be secured in the gap 8 byplacing a fixation plate 20 over the re-angling device 612, as FIG. 11Bshows. The fixation plate 20 can be attached to the bone 6 using atleast one fixation member 24. The fixation member 24 preferably extendsthrough the fixation plate 20 and into the bone 6 to secure there-angling device 612 to the bone 6. In the illustrative embodiment, thefixation member 24 comprises at least one screw, however any appropriatefixation member 24 may be utilized without departing from the invention.In FIG. 11B, the re-angling device 612 is oriented so that the hole 44receives the stem 46 of a total joint replacement. In other embodiments,the device 612 may be oriented so that the hole receives a pin 48 (FIG.11C) or a screw 50 (FIG. 11E), which can be installed using standardsurgical procedures known in the art. The pin 48 or screw 50 secures there-angling device 612 to the bone through the hole 44. In thesearrangements, a fixation plate 20 (as shown in FIG. 11B) need not beprovided, but optionally, it can be, if additional fixation is desired.

It may be desirable to provide the fixation plate 20 or plates with atleast one preformed aperture 34 through which a fixation member 24 mayextend to secure the fixation plate 20 to the bone 6, as shown in FIGS.6A and 6B. The aperture 34 may be threaded or not threaded.

The re-angling device 612 and fixation members 20, 24, 46, 48, and 50may be formed of any appropriate prosthetic material as describe above,and if desirable may include surfaces adapted to promote bony-in-growthas also described above.

The foregoing is considered as illustrative only of the principles ofthe invention. Furthermore, since numerous modifications and changeswill readily occur to those skilled in the art, it is not desired tolimit the invention to the exact construction and operation shown anddescribed. While the preferred embodiment has been described, thedetails may be changed without departing from the invention, which isdefined by the claims.

1. A system comprising a body sized and shaped to re-align a bone regiontoward a desired anatomic position; and at least one fixation member forsecuring the body to the bone region.
 2. A system according to claim 1wherein the fixation member includes at least one fixation plate sizedand configured for association with the body to secure the body to thebone region.
 3. A system according to claim 1 wherein the fixationmember includes at least two fixation plates each sized and configuredfor association with the body to secure the body to the bone region. 4.A system according to claim 1 wherein the fixation member comprises atleast one screw.
 5. A system according to claim 1 wherein the fixationmember comprises at least one staple.
 6. A system according to claim 5wherein the staple comprises at least one barbed staple.
 7. A systemaccording to claim 1 wherein the body includes at least one apertureformed through it sized and configured for engagement with a fixationmember.
 8. A system according to claim 7 wherein the aperture includesinternal threads.
 9. A system according to claim 1 wherein the body isgenerally wedge-shaped.
 10. A system according to claim 1 wherein saidthe fixation member includes a fixation plate formed with a firstsurface geometry, and wherein the body includes a second surfacegeometry that mates with the first surface geometry.
 11. A systemaccording to claim 10 wherein the first surface geometry comprises atleast one projection and the second surface geometry comprises at leastone mating aperture, or vice versa.
 12. A system according to claim 1further comprising a total joint replacement including a stem; andwherein the body includes an aperture formed through it sized andconfigured for engaging the stem.
 13. A system according to claim 1wherein at least one of the body and the fixation member comprises aprosthetic material.
 14. A system according to claim 1 wherein at leastone of the body and the fixation member comprises a biological material.15. A system according to claim 1 wherein at least one of the body andthe fixation member includes a region permitting bony in-growth and/orthrough-growth.
 16. A system of claim 1 wherein said fixation member andthe body are integrally formed.
 17. An osteotomy device comprising agenerally wedge-shaped body; and at least one intramedullary postextending from the wedge-shaped body.
 18. A method comprising providinga body sized and shaped to re-align a bone region toward a desiredanatomic position and at least one fixation member for securing the bodyto the bone region, selecting an bone region; forming a cavity in thebone region sized and configured to receive the body; inserting the bodyin the bone region to re-aligned the bone region toward a desiredanatomic position; and fixing the body to the bone region with thefixation member.
 19. A method comprising providing a body sized andshaped to re-align a bone region toward a desired anatomic position andat least one fixation plate sized and configured for association withthe body to secure the body to the bone region; selecting an boneregion; forming a cavity in the bone region sized and configured toreceive the body; inserting the body in the bone region to re-alignedthe bone region toward a desired anatomic position; and fixing the bodyto the bone region with the fixation plate.
 20. A method comprisingproviding a body sized and shaped to re-align a bone region toward adesired anatomic position, the body including at least one apertureformed through it sized, and a fixation member sized and configured forengagement with aperture; selecting an bone region; forming a cavity inthe bone region sized and configured to receive the body; inserting thebody in the bone region to re-aligned the bone region toward a desiredanatomic position; and fixing the body to the bone region by engagingthe fixation member through the aperture.